paliperidone

Generic: paliperidone

Labeler: archis pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paliperidone
Generic Name paliperidone
Labeler archis pharma llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paliperidone 6 mg/1

Manufacturer
Archis Pharma LLC

Identifiers & Regulatory

Product NDC 72819-159
Product ID 72819-159_4745a6d1-d9f5-2ff9-e063-6394a90a2825
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203802
Listing Expiration 2026-12-31
Marketing Start 2022-04-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72819159
Hyphenated Format 72819-159

Supplemental Identifiers

RxCUI
672567 672569 672571
UNII
838F01T721
NUI
N0000175430

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name paliperidone (source: ndc)
Generic Name paliperidone (source: ndc)
Application Number ANDA203802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-159-03)
source: ndc

Packages (1)

72819-159-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-159-03)

Ingredients (1)

paliperidone (6 mg/1)

Linked Drug Pages (1)

Paliperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4745a6d1-d9f5-2ff9-e063-6394a90a2825", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571"], "spl_set_id": ["e713556e-028e-0f4c-e053-2995a90a9e9f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Archis Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-159-03)", "package_ndc": "72819-159-03", "marketing_start_date": "20220427"}], "brand_name": "Paliperidone", "product_id": "72819-159_4745a6d1-d9f5-2ff9-e063-6394a90a2825", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72819-159", "generic_name": "paliperidone", "labeler_name": "Archis Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "6 mg/1"}], "application_number": "ANDA203802", "marketing_category": "ANDA", "marketing_start_date": "20220427", "listing_expiration_date": "20261231"}